Publications by authors named "Talley Mitchell"
Regulatory landscape with U.S. patient requirements and Clinical Trial Diversity expectations.
Contemp Clin Trials Commun
December 2024
Article Synopsis
- The FDA requires marketing authorization for products to include clinical data that reflects the US patient population, emphasizing the need for ethnically diverse foreign clinical data conducted under Good Clinical Practices.
- The recent Omnibus Legislation gives the FDA the power to mandate Diversity Plans for Phase 3 clinical trials, aiming to improve participation from underrepresented racial and ethnic groups.
- A guidance document issued by the FDA outlines expectations for sponsors on foreign clinical data and enrollment strategies for diverse populations in clinical trials, with an update anticipated in 2023.